Informatics System for Adverse Events in Cancer

Recruiting at 1 trial location

Overseen By Danielle Bitterman, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Brigham and Women's Hospital

Must be taking: Immuno-oncology therapeutics

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new system to efficiently catch and track side effects from immunotherapy, a cancer treatment that boosts the immune system. The researchers aim to determine if computer software can automatically check patients' medical records to identify side effects faster and enroll more people into a research database. Participants will have their records checked either by the usual method or with the new software, called the informatics system for eligibility monitoring, to compare effectiveness. The trial seeks individuals currently receiving or who have received immunotherapy treatments. As a Phase 1 and Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in cancer care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on monitoring immune-related side effects from cancer treatments.

What prior data suggests that this informatics system is safe for monitoring irAEs?

Research shows that special computer systems safely monitor health records for signs of side effects from cancer treatments. These systems check electronic health records to detect side effects early. Studies with similar systems have shown they are generally well-tolerated. No reports of harm have emerged from using this technology, as it only analyzes data and does not interact with the body. Since this study is in its early stages, it focuses primarily on testing the system's ability to spot side effects, not on causing any harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the informatics-assisted monitoring system for cancer patients because it integrates advanced technology to enhance standard monitoring practices. Unlike traditional methods that rely solely on manual tracking of adverse events, this system uses data analytics to continuously monitor patient eligibility and detect immune-related adverse events (irAEs) more efficiently. This innovative approach aims to provide real-time insights, potentially leading to quicker interventions and improved patient outcomes. By combining standard monitoring with informatics assistance, it holds the promise of more precise and personalized care for cancer patients.

What evidence suggests that this informatics system is effective for improving registration to an irAE biorepository?

Research has shown that using technology to track immune-related side effects in cancer patients holds promise. In this trial, participants will receive either standard monitoring or informatics-assisted monitoring, which combines standard monitoring with additional technology support. Studies have found that electronic monitoring systems can catch symptoms early, enhancing patient care management. These systems automatically read electronic health records (EHRs) to detect side effects, improving the frequency of patient registration in biorepositories. Evidence from similar systems indicates these methods can speed up and improve the accuracy of side effect detection, enhancing patient care efficiency. Overall, technology-assisted monitoring has the potential to make managing side effects more effective. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with uterine tumors or cancer who are currently receiving or have received immunotherapy. The study aims to improve how quickly and accurately patients experiencing immune-related side effects are added to a biorepository that collects health data.

Inclusion Criteria

I am receiving or have received cancer treatment that includes immunotherapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Feasibility Run-in

Initial feasibility run-in with the first 10-20 patients to establish the feasibility of the informatics system

2 months

Monitoring

Participants are monitored for irAEs through daily automated analysis of their EHR data

12 months

Follow-up

Participants are monitored for safety and effectiveness after the main monitoring phase

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Informatics system for eligibility monitoring

Trial Overview The study tests if an informatics system, which automatically checks electronic health records, can better detect immune-related adverse events compared to standard monitoring. It evaluates the feasibility of this system and its impact on registration rates into a biorepository.

How Is the Trial Designed?

Group I: Standard monitoring Experimental Treatment 1 Intervention

Standard irAE monitoring for an eligible registration event.

Group II: Informatics-assisted monitoring Experimental Treatment 2 Interventions

Informatics-assisted monitoring plus standard monitoring

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12223247/

Effectiveness of symptom monitoring on electronic patient ... Symptom monitoring using electronic patient-reported outcomes (ePROs) has demonstrated benefits for patients with cancer, yet the systematic ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06789601

Evaluating Informatics-assisted Immune-related Adverse ... This is a single institution, randomized controlled trial of an informatics system for automated immune-related adverse event (irAE) detection from the ...

3. ascopubs.org ascopubs.org/doi/10.1200/CCI-25-00023

Machine Learning–Based Prediction of Clinical Outcomes ... This study aimed to investigate whether changes in step count, measured using patients' own smartphones, could predict a clinical adverse event in the upcoming ...

4. withpower.com withpower.com/trial/phase-2-immune-related-adverse-events-8-2025-3cd53

Informatics System for Adverse Events in Cancer Trial Overview The study tests if an informatics system, which automatically checks electronic health records, can better detect immune-related adverse events ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/17407745251378668

Electronic patient-reported adverse event monitoring in ... Adverse event monitoring is essential to monitor safety for oncology patients on early-phase clinical trials.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10668225/

Registry study of immune-related adverse events using ... This study primarily aims to obtain a database for descriptive research on the status of irAEs using the Patient-Reported Outcomes version of the Common ...

7. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/572836

Evaluating Informatics-assisted Immune-related Adverse ... The informatics system automatically "reads" participants' electronic health records (EHRs) and determines whether that patient may be experiencing an irAE. The ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0959804923008079

The side effect registry immuno-oncology (SERIO) – A tool ... Data from SERIO generates insights into irAE prevalence, pathogenesis, management and outcome. Given the efficacy of immunotherapy, many cancer patients are now ...